Endometrial Adenocarcinoma
Conditions
Keywords
Endometrial carcinoma, Molecular classification, Adjuvant therapy
Brief summary
The goal of this clinical trial is to compare the efficacy of adjuvant therapies in women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. Specifically, the invesigators want to compare: * Chemotherapy vs. chemoradiotherapy in p53 abn subtype and nonendometrioid carcinomas. * Vaginal brachytherapy vs. whole pelvic radiotherapy in the MMR-D molecular subgroup. * Vaginal brachytherapy vs. whole pelvic radiotherapy in the NSMP molecular subgroup.
Detailed description
Endometrial carcinomas can be classified into four molecular subgroups, i.e. mismatch repair deficient (MMR-D), p53 abnormal (p53 abn), polymerase-ϵ (POLE) ultramutated, and no specific molecular profile (NSMP). Molecular subgroups can be considered to be distinct diseases as they are associated with different clinicopathologic characteristics, prognoses and, possibly, responses to adjuvant therapy. Molecular classification of endometrial carcinoma is recommended to be implemented in routine clinical practice to improve prognostication and triage to adjuvant therapy. The PErsonalized TReatment for Endometrial Carcinoma (PETREC) trial, led by the Finnish Gynecologic Oncology Group (FINGOG), is a multicenter prospective clinical trial for women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. The efficacy of chemotherapy vs. chemoradiotherapy is compared in p53 abn subtype and nonendometrioid carcinomas, and vaginal brachytherapy vs. whole pelvic radiotherapy in MMR-D and NSMP molecular subgroups. Patients who consent to follow-up within the trial but not to randomization are treated as recommended in multidisciplinary meetings and enrolled for follow-up only (comprehensive cohort study design). The primary outcome is the 5-year cumulative incidence of disease recurrence. Secondary outcomes are vaginal, pelvic, and distant recurrence rates, 5-year recurrence-free and overall survival, adverse events, and patient-reported symptoms and quality of life. The findings of the trial may eventually help decrease under- and overtreatment and, consequently, improve patient outcome and decrease treatment-associated adverse effects.
Interventions
OTHERComparison of chemotherapy vs. chemoradiotherapy
Chemotherapy (paclitaxel-carboplatin) vs. chemoradiotherapy (paclitaxel-carboplatin followed by whole pelvic radiotherapy) Patients assigned to chemotherapy receive paclitaxel (175 mg/m2) and carboplatin (area under curve, 5) every 3 weeks for 6 cycles. The pelvic radiotherapy dose is 45 to 50.4 Gy over 5 to 6 weeks (1.8 Gy per day for 25 to 28 fractions).
OTHERComparison of VBT vs. WPRT
Vaginal brachytherapy vs. whole pelvic radiotherapy Patients randomized to vaginal brachytherapy receive cuff brachytherapy at 21 Gy in 3 fractions of 7 Gy at 0.5 cm depth. The pelvic radiotherapy dose is 45 to 50.4 Gy over 5 to 6 weeks (1.8 Gy per day for 25 to 28 fractions).
Sponsors
Turku University Hospital
Tampere University Hospital
Kuopio University Hospital
Oulu University Hospital
Kymenlaakso Central Hospital Kotka Finland
Päijänne Tavastia Central Hospital
South Carelia Central Hospital
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comprehensive cohort design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 100 years * WHO performance status 0 to 2 * Stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma
Exclusion criteria
* Age \<18 years or \>100 years * WHO performance status \>2 * Uterine sarcoma * A history of malignancy within 5 years * Previous pelvic radiotherapy * An interval of \>30 days between surgery and start of chemotherapy or \>8 weeks between surgery and start of radiotherapy (longer intervals may be permitted with investigator´s approval)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer reappearance | 5 years | Cumulative incidence of disease recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Location of cancer reappearance | 5 years | Vaginal, pelvic, and distant recurrence rates |
| Overall survival | 5 years | The time from surgery to death |
| Recurrence-free survival | 5 years | The time from surgery to cancer recurrence |
| Adverse events | 5 years | Adjuvant therapy-related adverse events |
Countries
Finland
Contacts
Primary ContactMikko Loukovaara
Backup ContactRalf Bützow
Outcome results
None listed